Download (butalbital-acetaminophen), butalbital-aspirin-caffeine

Butalbital Analgesics
Allzital (butalbital-acetaminophen), butalbital-aspirin-caffeine, butalbitalaspirin-caffeine-codeine, butalbital-acetaminophen, butalbitalacetaminophen-caffeine, butalbital-acetaminophen-caffeine-codeine,
Vanatol LQ (butalbital-acetaminophen-caffeine liquid oral solution)
RATIONALE FOR INCLUSION IN PA PROGRAM
Background
Butalbital containing products are non-opioid analgesics that contain a combination of different
drug products indicated for the relief of the symptom complex of tension (or muscle contraction)
headache pain. Butalbital is a short to intermediate-acting barbiturate that works in concert with
acetaminophen, an antipyretic non-salicylate agent, aspirin, a pain-relieving NSAID, and caffeine, a
stimulant that works in the CNS, to decrease pain via a mechanism that isn’t well understood.
Butalbital is a habit-forming drug that potentiates the effects of other commonly abuse drugs or
substances like alcohol. Caffeine might help increase vasodilation and smooth muscle relaxation,
while butalbital is thought to help balance the CNS stimulation caused by caffeine and produces
depressant effects (1).
Regulatory Status
FDA approved indication: Butalbital containing products are used in the relief of the symptom
complex of tension or muscle contraction headaches (2-9).
Frequent use of acute medications is generally thought to cause medication-overuse headache. To
decrease the risk of medication-overuse headache (“rebound headache” or “drug-induced
headache”) many experts limit acute therapy to two headache days per week on a regular basis.
Based on concerns of overuse, medication-overuse headache, and withdrawal, the use of
butalbital-containing analgesics should be limited and carefully monitored. The Allzital limit is set to
the maximum of 12 doses per day for acute treatment of 8 headaches per month as this product
contains less butalbital than other products. The quantity limit for all other butalbital products is set
to the maximum of 6 doses per day for acute treatment of 8 headaches per month (10).
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver
transplant. Most of the cases of liver injury are associated with the use of acetaminophen at doses
that exceed 4000 milligrams per day, and often involve more than one acetaminophen -containing
product. Instruct patients to look for acetaminophen or APAP on package labels and not to use
more than one product that contains acetaminophen. (5-6).
Butalbital Analgesics FEP Clinical Rationale
Butalbital Analgesics
Allzital (butalbital-acetaminophen), butalbital-aspirin-caffeine, butalbitalaspirin-caffeine-codeine, butalbital-acetaminophen, butalbitalacetaminophen-caffeine, butalbital-acetaminophen-caffeine-codeine,
Vanatol LQ (butalbital-acetaminophen-caffeine liquid oral solution)
Safety and effectiveness of Allzital, butalbital-acetaminophen, butalbital-acetaminophen-caffeine,
and Vanatol LQ in patients below the age of 12 have not been established. Safety and
effectiveness of butalbital-acetaminophen-caffeine-codeine, butalbital-aspirin-caffeine, and
butalbital-aspirin-caffeine-codeine in patients below the age of 18 have not been established (2 -9)
Summary
Butalbital is a short to intermediate-acting barbiturate that causes CNS depression. Caffeine is a
CNS stimulant that is thought to help increase vasodilation (smooth muscle relaxation).
Acetaminophen might help decrease pain sensation in the peripheral nervous sys tem by blocking
those signals. Aspirin is an NSAID that decreases pain and swelling by blocking prostaglandins.
Butalbital-containing analgesics are FDA approved for the treatment of the symptom complex of
tension or muscle contraction headache. These products can have pronounced sedative effects
and butalbital is habit-forming (1-10).
Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of
butalbital-containing analgesics, while maintaining optimal therapeutic outcomes.
References
1. Bryczkowski, C., Geib, A.J. Combined Butalbital/Acetaminophen/Caffeine Overdose: Case
Files of the Robert Wood Johnson Medical School Toxicology Service. Journal of Medical
Toxicology, Sept. 26, 2012.
2. Vanatol LQ [package insert]. Arlington, TX GM Pharmaceuticals, Inc.; Revised March 2015.
3. Fiorinal [package insert]. Morristown, NJ: Watson Pharma, Inc.; February 2014.
4. Fiorinal with Codeine [package insert]. Morristown, NJ: Watson Pharma, Inc.; February
2014.
5. Fioricet [package insert]. Parsippany, NJ: Watson Pharma, Inc.; April 2014.
6. Fioricet with Codeine [package insert]. Parsippany, NJ: Watson Pharma, Inc.; April 2014.
7. Phrenilin tablet and Phrenilin Forte capsule [package insert]. Bridgewater, NJ: Valeant
Pharmaceuticals North
America LLC; December 2014.
8. Phrenilin capsule [package insert]. Aliso Viejo, CA: Valeant Pharmaceuticals North
America; October 2011.
9. Allzital [package insert]. Canton, MS: Larken Laboratories, Inc.; August 2015.
10. Beithon J, Gallenberg M, Johnson K, et al. Institute for Clinical Systems Improvement.
Diagnosis and Treatment of Headache. https://www.icsi.org/_asset/qwrznq/Headache.pdf.
Updated January 2013. Accessed May 2015.
Butalbital Analgesics FEP Clinical Rationale